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Found 16 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 more effectively than a placebo. This Phase 3 randomized, placebo-controlled, double-blind study focuses on non-hospitalized adults at high risk of severe disease progression due to COVID-19. The study addresses the need for alternative treatments for people who cannot take certain COVID-19 medications due to availability or potential drug interactions. Participants will receive either molnupiravir or a placebo, both given orally as two 400 mg film-coated tablets every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if clinically appropriate and available. The study compares the effects of molnupiravir with placebo in preventing severe illness outcomes. Throughout the study, participants will be monitored for outcomes such as hospitalization, death, or medically attended visits related to COVID-19 up to 29 days. Safety is assessed by tracking adverse events for up to about 5 months and discontinuation of study treatment due to adverse events for about 5 days. The study involves laboratory tests, symptom assessments, and safety evaluations to understand molnupiravir's impact on disease progression and participant health.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of enicepatide, a dual GLP-1/GIP receptor agonist, for managing weight in adults with obesity or overweight who also have Type 2 diabetes mellitus (T2DM). This Phase III study compares multiple doses of enicepatide to a placebo to understand its impact on weight loss in this population. Participants receive either enicepatide or a placebo once weekly through an integrated drug-device combination. The study uses a randomized, double-blind, placebo-controlled design to assess the effects of the treatment. The placebo is volume-matched and administered using the same method as the active drug. During the study, participants will have their body weight changes measured up to week 72 to assess efficacy. Researchers will monitor weight changes as the primary outcome. Participants must be able to self-administer the injections or receive them from a trained individual, and their safety and adherence will be observed throughout the study period.
Actively Recruiting
Researchers are conducting a phase 3 study to evaluate the safety and effectiveness of orforglipron for treating hypertension in adults who are overweight or have obesity. The study framework supports two independent trials and aims to better understand how orforglipron works in this specific population with high blood pressure and excess weight. Participants receive orforglipron or a placebo orally once daily. The study includes screening and baseline visits to confirm eligibility based on blood pressure and body mass index. Treatment is randomized and double-blind, meaning neither participants nor researchers know who receives the active medication or placebo during the trial. Throughout the study, researchers monitor blood pressure and other health factors to assess the number of participants assigned to each treatment group. Safety and efficacy are evaluated regularly, with ongoing observation of participants’ response to the medication and any potential side effects.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of orforglipron for treating people who have both hypertension and are either overweight or obese. This study is part of a larger master protocol called GZPL and focuses specifically on these health conditions. The trial is designed as a Phase 3 study to provide important information about this potential treatment. Participants will receive either orforglipron or a placebo, both given orally once daily. The study compares these two groups to understand the impacts of orforglipron on blood pressure and weight-related health issues. The treatment period lasts up to 36 weeks, during which participants are monitored closely. During the study, participants will have their office systolic blood pressure measured to track changes from the start of the trial to week 36. Researchers will also monitor safety and other health measures throughout the trial. The study involves regular visits and assessments to ensure participant well-being and to gather thorough data on the treatment's effects.
Actively Recruiting
This research aims to assess the effectiveness and safety of orforglipron for treating hypertension in adults with obesity or overweight. It is conducted as part of the GZPL master protocol and focuses on participants who have both high blood pressure and elevated body weight. The study is designed as a Phase 3 clinical trial to provide detailed evaluation of this new treatment approach. Participants will receive either orforglipron or a placebo, both given orally once daily. The study compares these two groups to understand the benefits and any side effects of orforglipron when used for managing hypertension in this specific population. The treatment period and detailed dosing schedule are based on the master protocol, which guides participant management and study procedures. During the study, participants will have their systolic blood pressure measured regularly to track changes from the start through week 36. Researchers will monitor safety and treatment effects closely, following all procedures outlined in the master protocol. The overall duration of participant involvement and additional assessments are determined by the master protocol guidelines for this comprehensive evaluation.
Actively Recruiting
Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.
Actively Recruiting
Researchers are evaluating the effectiveness and safety of brenipatide compared to a placebo in reducing the chance of relapse to cigarette smoking in adults who have recently quit. This is a Phase 2, multicenter, randomized, double-blind study focused on adults aged 18 to 75 who want to maintain abstinence from smoking. The study aims to measure continuous abstinence confirmed by carbon monoxide levels from week 1 through week 24. Participants will receive either brenipatide or placebo administered subcutaneously during a 24-week treatment period. The study includes a 2-week screening phase before treatment begins and an 8-week safety follow-up after treatment ends. Treatment involves self-injection of the study drug or placebo, and participants are expected to attend up to 17 study visits throughout the approximately 34-week study duration. During the study, participants will be monitored regularly to confirm smoking abstinence and assess safety. Researchers will measure the percentage of participants who maintain continuous abstinence from smoking, verified by carbon monoxide levels. The study includes evaluation of adherence to treatment, safety assessments, and follow-up visits to monitor participants for any adverse effects or relapse.
Actively Recruiting
Researchers are evaluating the change in hemoglobin A1c (HbA1c) levels in people with type 2 diabetes who have not reached their HbA1c goal despite stable treatment with semaglutide or tirzepatide. This phase 2, double-blind study compares the effects of LY3457263, a drug given by subcutaneous injection, with a placebo in this patient group. Participants will be adults aged 18 to 75 with type 2 diabetes and specific HbA1c and BMI criteria. Participants will receive either LY3457263 or a placebo, both administered once weekly by subcutaneous injection. All participants must be on a stable dose of either injectable semaglutide or tirzepatide for at least three months before the study. The treatment period is 24 weeks, during which researchers will monitor changes in HbA1c levels from the start of the study. Throughout the study, participants will undergo assessments to measure HbA1c at the beginning and at week 24. The total participation duration is about 9 months. Researchers will also track participants' safety and treatment adherence during this time to evaluate the effects of LY3457263 compared to placebo in managing type 2 diabetes.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of solbinsiran in reducing triglycerides and other fat-related measures in adults with severe hypertriglyceridemia. This phase 2 study compares solbinsiran to a placebo to better understand its potential benefits and risks in this condition. Participants will receive two subcutaneous injections of either solbinsiran or a placebo. The study is randomized and double-blind, meaning neither the participants nor the researchers know who receives the actual drug or placebo during the treatment period. Participants will be monitored for changes in their triglyceride levels from baseline through weeks 16 to 24. The study tracks safety and efficacy by measuring lipid changes and observing any side effects. The total duration of participation includes screening and treatment phases with regular assessments throughout the study.
Actively Recruiting
Researchers are evaluating the effectiveness of selnoflast compared with a placebo in people with atherosclerosis who are at high risk for major adverse cardiovascular events (MACE) and are already receiving standard-of-care treatment. This Phase IIa study aims to assess the safety, pharmacodynamics, and pharmacokinetics of selnoflast in reducing vascular inflammation in this population. Participants will receive either selnoflast or a placebo according to the assigned treatment schedule. The study is randomized, double-blind, and placebo-controlled, ensuring that neither participants nor researchers know who receives the active drug or placebo. Treatment is given under stable conditions alongside standard therapies for atherosclerosis. Throughout the study, participants will undergo assessments including imaging scans to measure vascular inflammation, specifically changes in target-to-background ratio (TBR) in affected blood vessels from baseline to Week 12. Regular monitoring will include electrocardiograms and laboratory tests to evaluate safety and treatment effects over the study period.
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